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I have interviewed an expert in the Air Force communications field. He has 18 years or more experience in the field. Most of what is done in the Air Force can't be done

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

without comm. support - and the operational commanders know it. He has done AIA (Intel), H.F., V.H.F., U.H.F., SATCOM, mobility, A.T.C., P.A., and Q.A. He has done it fr

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

om the airmen side to the NCOIC side.

"I was Chief of the Systems Flight at MacDill A.F.B. when it was still home of the 56th Comm. Squadron. We had all the functions y

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ou mentioned above, plus the base telephone company, weather radars, NAVAIDS, DMSP, and a couple of others that might have slipped my mind. On the HF side, we had transm

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

itter, receiver, and antenna maintenance, plus HF ops, and a MARS station that was just absolutely off the map during Operation Desert Storm."

"Currently NCOIC is a gro

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

nd radio shop. In only 8 years I've been exposed to everything from H.F. to E.H.F. systems. You just don't see many A.F.S.C.'s that can vary so much base to base. And, w

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ithout any undue modesty, our people are some of the best. All you have to do is attend a few Leadership School and NCO Academy graduations and keep track of where the D

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

istinguished Grads and Honor Grads come from. You'll find that the trend is (in no particular order) Comm. guys (various AFSCs); Air Traffic Control (tower flowers usual

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ly do well, too); and Med/Hospital."

"Current HF radio configurations. When I was at MacDill, we had a GCCS site. Our H.F. Radio Ops and Receivers were co-located at on

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

e site; transmitters were down the road and across the base, with a couple of miles of separation between RX and TX, to minimize cross-talk."

"There are some ground rad

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

o operator from 1969-73 in Vietnam. A.F.S.C. then went to 293x0 which changed to 293x3 later on. They went to the air borne radio from 1973-78 then back to ground while

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

in Germany. Finish my carier in Combat Crew Communications at F.E Warren AFB."

"The new Ground Radio course is 73 academic days (14.6 weeks) long with 9 hr. class days.

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

Add the 7 weeks of Electronics Principles and there's your grand total (21.6 weeks). This does not mean that's how long you'll be at Keesler because that is the minimum

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

amount of time to complete the school and you will learn that you're training status varies from time to time and may slow your progression through training. Also, the

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

course is subject to change because this is more or less an experiment until they get everything the way they want it."

"From the last time that I had heard of it is sh

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

rter because it's a tactical course yes, but no merger yet. That's been in the rumor mill for a while. But when you go to this school you need to consider holidays and C

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

hristmas exodus for training as well. My training is only 27 weeks but a guy told me it took him 7 or 8 months. I all depends on what course you take and how well your u

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

nit dose on that course. But some of them have had to take up to ten extra mouths at school just to finish there course."

"Some people expect to hear of the merger w/ S

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

atcom pretty soon. The civilian at Keesler in charge of 2E training came up to my tech school (I was an instructor for Satcom/Wideband) and said the only reason the merg

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

er hasn't really gotten a head of steam yet was the hurricane. That pushed everything to the back burner. But expect the head of steam to pick up (if it hasn't already).

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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